A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).

Merck Sharp & Dohme LLC30 enrolled

Overview

Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Skin Androgenization

Interventions

testosterone gelDRUG

300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks

Comparator: placeboDRUG

transdermal placebo gel for 6 weeks

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is at least 3 years postmenopausal * Subject is in good general health * Subject is willing to avoid excess alcohol or strenuous physical activity during the study Exclusion Criteria: * Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks * Subject is a regular user of any illicit drugs * Subject drinks excessive amounts of coffee, tea or cola * Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months * Subject has a history of cancer * Subject has acne

Outcomes

Primary Outcomes

serum free testosterone concentrations following multiple doses of AndroGel

Time frame: 6 weeks

Secondary Outcomes

mean percent change from baseline in sebum excretion

Time frame: 6 weeks

Data from ClinicalTrials.gov

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